Bristol-Myers Squibb Co. and Pfizer Inc. have received Food and Drug Administration approval for their Supplemental New Drug Application (sNDA) for Eliquis (apixaban), indicated to treat prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

Bristol-Myers, Pfizer gain FDA approval for Eliquis

March 17th, 2014

PRINCETON, N.J., and NEW YORK – Bristol-Myers Squibb Co. and Pfizer Inc. have received Food and Drug Administration approval for their Supplemental New Drug Application (sNDA) for Eliquis (apixaban), indicated to treat prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

"Today's FDA approval of Eliquis for DVT prophylaxis in patients who have undergone hip or knee replacement is a significant milestone for this important medicine, which is also approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation," Brian Daniels, senior vice president of global development and medical affairs at Bristol-Myers Squibb, said in a statement on Friday. "This approval reflects the continued commitment of the alliance to deliver new treatment options for patients and physicians."

Each year in the United States, an estimated 719,000 total knee replacement surgeries and 332,000 hip replacement surgeries are performed, Bristol-Myers and Pfizer reported. Patients undergoing hip or knee replacement surgery without thromboprophylaxis are at risk for developing DVT and PE.

Guidelines recommend the use of anticoagulants for the prophylaxis of DVT and PE for most patients undergoing orthopedic surgery.

"As the number of hip and knee replacement surgeries performed in the U.S. continues to increase, the risk of DVT following these surgeries remains a concern for physicians," stated Steven Romano, senior vice president and Medicines Development Group head for Pfizer's Global Innovative Pharmaceuticals Business. "Eliquis provides patients and physicians with a new treatment option that offers twice daily oral dosing and no routine coagulation testing and is broadly accessible through hospitals and managed health care formularies."

A blood clot that forms in a large vein, usually in the lower leg, thigh or pelvis, DVT can lead to PE when a portion or all of a blood clot breaks off and travels to the lungs, blocking one or more blood vessels. PE can lead to sudden death.

"DVT, which may lead to PE, is a serious medical condition," noted Richard J. Friedman, M.D., professor of orthopedic surgery at the Medical University of South Carolina. "The FDA approval of Eliquis gives U.S. orthopedic surgeons a new option for DVT prophylaxis in both hip and knee replacement surgery."